Dynocardia - Financial Conflict of Interest (FCOI) Policy
PHS Regulations and guidance require specific processes for compliance, not simple recitation of requirements.
Training Requirement
The Institution shall inform, and complete training of the Covered Individuals regards to PHS Regulations, FCOI Policy, and Covered Individuals disclosure responsibilities. Institutions training will use information and other resources developed by NIH, presently at https://grants.nih.gov/grants/policy/coi/index.htm
The training shall be given to each Covered Individual (i) Prior to engaging in PHS Research, (ii) for each new Covered Individual upon hire, (iii) each time there is a change in requirements for Covered Individual in this Policy (to the extent required to train the Covered Individual on the new material implemented), (iv) whenever a Covered Individual has been found not to be following this policy, and (v) no less than every four years or as designated based on grant or role circumstances.
Disclosures, Compliance, Enforcement Mechanisms, Remedies and Penalties
This section explains the process Covered Individuals should follow to make their disclosures including sub recipient Covered Individuals. The section also explains the policy for failure to make a disclosure.
The Institution designates Bob Gallagher (The Controller), as the institutional official to solicit and review disclosures of SFI from each Covered Individual who is planning to participate in, or is participating in, PHS Funded Research.
Disclosing SFI and FCOI: Disclosures are made on an annual basis. Covered Individuals should fill the Financial Conflict of Interest - Disclosure Form (FCOI- DF) before the end of February every year. By submitting the FCOI- DF, Covered Individuals acknowledge, among other things, the Institution's policy on FCOI, the Covered Individual's responsibilities regarding disclosure of SFI, and of 42 CFR 50, subpart F, Promoting Objectivity in Research
If there has been a change since the annual disclosure or if a Covered Individual did not submit the annual FCOI- DF, Covered Individuals must submit a FCOI- DF immediately.
The FCOI- DF are reviewed by the Controller and when a disclosure is made, will follow up with the Covered Individual for more information. This additional information will assist with determining whether the disclosure relates to the Covered Individual Responsibilities and if so whether there is a FCOI.
In addition to the need to disclose FCOI to the Institution, it is also important that such conflicts be disclosed to others who might be affected by the research. This includes, for example, human subjects, other researchers who might rely on the research results, and the public. It is expected that all Covered Individuals will disclose FCOI related to specific research projects at any time that the results of that research are presented or published.
At the time of the application/proposal submission, Institution shall certify, in each application for funding that it has an up-to-date written, and enforced administrative process to identify and manage, reduce, or eliminate FCOI with respect to all research projects for which funding is sought or received. Institution additionally certifies that it will: promote and enforce Covered Individual compliance with this policy's requirements including those pertaining to disclosure of SFI; manage FCOI and provide initial and ongoing FCOI reports to the PHS Awarding Component; make information available, promptly upon request, to the PHS Awarding Component relating to any Covered Individual disclosure of FCOI and Institution' review of, and response to, such disclosure, whether or not the disclosure resulted in the Institution's determination of a FCOI; and fully comply with the requirements of 42 CFR 50., Promoting Objectivity in Research.
Regulations apply to Subgrantees, Collaborators of Grantees (e.g. consortia) or Subcontractors:
See Subawards for PHS Research Effort
New Covered Individuals and New Disclosures by Existing Covered Individuals: Whenever, in the course of an ongoing PHS-Funded Research, a Covered Individual who is new to participating in the PHS Funded Research discloses a SFI or an existing Covered Individual discloses a new SFI to the Institution, the Controller will, within thirty (30) days: review the disclosure of the SFI; determine whether it is related to federally-funded research; determine whether a FCOI exists; and, if so, implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such FCOI going forward.
Untimely Disclosures and Retrospective Review: In addition, whenever a FCOI is not identified or managed in a timely manner including failure by the Covered Individual to disclose a SFI that is determined by the Institution to constitute a FCOI; failure by the Institution to review or manage such a FCOI; or failure by the Covered Individual to comply with a FCOI management plan, the Institution will, within 120 days of its determination of noncompliance, complete a retrospective review of the Covered Individual's activities and the PHS Funded Research to determine whether any research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research.
Failure to Disclose a Conflict of Interest: The Institution has established adequate enforcement mechanisms and provides for sanctions or other administrative actions to ensure Covered Individual compliance as appropriate.
Records Management
The records of all Financial Disclosures and all actions taken by the Institution will be maintained in an SFI binder or binders, The Controller is responsible for ensuring that records are placed in SFI binders and maintained the required time. SFI files may state a disposition date (the latest date) when they are full; such legends must be updated if a litigation, claim, negotiation, audit or other action involving the records require a later disposition date.
The Institution shall retain records of all financial disclosures and all actions taken by the Institution with respect to FCOI.
The Institution is required to keep all records as follows:
For grants or cooperative agreements – for at least three years from the date of submission of the final expenditures report or, where applicable, from other dates specified in 45 C.F.R. 74.53(b) for different situations
For research contracts – for three years after final payment or, where applicable, for the other time periods specified in 48 CFR part 4, subpart 4.7.